Answers - Legal

We are starting to see more and more Internet Laws being added to the

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

books in many different agencies in the United States. There are cyber

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

laws at the FBI, FCC, SEC, FTC and many other places cropping up. Wha

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

t is unfortunate indeed is that most of these laws are made to protect

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

US Citizens and yet only enforced onto US Citizens. We have Identity

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

Theft Laws, Child Porn, SPAM, Phishing and Hacking Laws and yet in rea

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

lity most of the criminals who specialize here are not US Citizens and

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

do not live in the US.

Perhaps as the Internet Started those sorts o

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

f criminals were from here, but not anymore, as the United States has

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

been cleaning up its act. Now these criminals come from other countrie

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

s and the Internet knows no bounds. They hide in far away countries an

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

d host their websites in far away cities, half way around the world an

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

d they prey on the US Citizens. Our Cyber Laws cannot protect the Amer

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ican People in this case.

Then there are those harassing slander laws

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

, which seem to be selectively enforced as well. Even the government i

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

tself slanders citizens on the Internet accusing them of things they d

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

id not do or purporting their side of the case in self-aggrandizement

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

prior to any court of law. It appears that in the future all these iss

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ues must be addressed other wise any cyber laws, which are made are ne

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ver going to stop the crime being committed. Consider all this in 2006

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Answers - Cyber Law and Slander Online Considered

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